• Hideo Baba, Naoko Hayashi, Yasunori Emi, Yoshihiro Kakeji, Akinori Egashira, Eiji Oki, Ken Shirabe, Tetsuo Toyama, Takefumi Ohga, Manabu Yamamoto, Hirofumi Hasegawa, Fumiko Kohakura, Hidefumi Higashi, Kiyoshi Niwa, Fumihiko Fujita, Yutaka Ogata, Shunji Kohnoe, Masafumi Inomata, Hironori Samura, Shoji Tokunaga, Yoshihiko Maehara, and Kyushu Study Group of Clinical Cancer (KSCC).
• Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
• Surg. Today. 2011 Dec 1; 41 (12): 1610-6.

PurposeThis multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer.MethodsSixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred.ResultsTwo patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%-48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients.ConclusionThe results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-line therapy for advanced colorectal cancer in the Japanese population.

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